目的 探讨定坤丹联合屈螺酮炔雌醇片（Ⅱ）治疗肾虚肝郁型多囊卵巢综合征的有效性及安全性。方法 选取2023年1月至2024年1月在广东省妇幼保健院就诊的120例多囊卵巢综合征（PCOS)患者，根据患者意愿分为研究组58例[采用定坤丹+屈螺酮炔雌醇片（Ⅱ）治疗]和对照组62例[仅采用屈螺酮炔雌醇片（Ⅱ）治疗]。比较两组患者用药前后的月经周期、中医证候积分、高雄激素血症临床体征、血清性激素、代谢指标、卵巢体积和窦卵泡计数、排卵率与妊娠率、肝肾功能等临床指标的差异，并记录药物不良反应。结果（1）两组患者停药后3个月内月经周期恢复情况比较，差异有统计学意义（P<0.05）。（2）治疗前后，研究组的体重指数（BMI）下降程度优于对照组（P<0.05）；两组患者的多毛改良Ferriman-Gallwey评分变化和Pillsbury痤疮等级改善情况，组间差异无统计学意义（P>0.05）。（3）研究组患者的中医证候积分下降程度优于对照组（P<0.05）。（4）研究组患者游离雄激素指数、血清总睾酮、雄烯二酮、黄体生成素与卵泡刺激素比值的下降均优于对照组（P<0.05）；两组雌二醇和卵泡刺激素组间差异均无统计学意义（P>0.05）。（5）代谢指标方面：研究组空腹胰岛素、胰岛素抵抗指数、甘油三酯、总胆固醇、血清尿酸的下降程度均优于对照组，高密度脂蛋白胆固醇的上升程度优于对照组（P<0.05）；而空腹血糖、低密度脂蛋白胆固醇、同型半胱氨酸的变化情况，两组差异并无统计学意义（P>0.05）。（6）卵巢体积和窦卵泡计数方面，两组差异均无统计学意义（P>0.05）。（7）排卵率方面，研究组的排卵率优于对照组（P<0.05）。（8）两组患者肝肾功能指标均未见异常，不良反应发生率两组差异无统计学意义（P>0.05）。结论 定坤丹联合屈螺酮炔雌醇片（Ⅱ）可改善肾虚肝郁型PCOS患者的月经周期，降低中医证候积分，降低总睾酮及雄烯二酮，改善糖脂代谢和尿酸代谢，提高排卵率。未发现药物不良反应发生率的增加。

Objective To investigate the efficacy and safety of Dingkundan in combination with drospirenone-ethinylestradiol tablets (Ⅱ) in the treatment of PCOS of kidney-deficiency and liver-stagnation type. Methods This trial enrolled 120 PCOS patients who attended Guangdong Women and Children Hospital from January 2023 to January 2024. Participants were divided into the experiemental group [Dingkundan + drospirenone-ethinylestradiol tablets（Ⅱ）] and the control group [drospirenone-ethinylestradiol tablets（Ⅱ）]. Changes in menstrual cycles, traditional Chinese medicine syndrome scores, physical features related to hyperandrogenism, serum sex hormones, metabolic indicators, ovarian volume and antral follicle count, ovulation rate and pregnancy rate, and liver and kidney functions before and after treatment were compared, and adverse reactions were also recorded. Results（1）The comparison of menstrual cycle recovery between the two groups of patients within 3 months after discontinuing medication showed significant differences (P<0.05).（2）Before and after treatment, the study group exhibited a greater reduction in body mass index compared to the control group (P<0.05). However, there were no significant statistical differences between the two groups regarding improvements in hirsutism as measured by the Ferriman-Gallwey score or acne severity as measured by the Pillsbury scale.（3）As for traditional Chinese medicine syndrome scores, the study group had a greater reduction(P<0.05).（4）In terms of endocrine parameters, the study group had a greater reduction in free androgen index, serum total testosterone, androstenedione, and luteinizing hormone/follicle-stimulating hormone ratio compared to the control group (P<0.05). Nonetheless, there were no significant statistical differences between the two groups in estradiol or follicle-stimulating hormone.（5）Regarding metabolism, the study group showed a greater reduction in fasting insulin, homeostasis model assessment of insulin resistance, triglycerides, total cholesterol, and serum uric acid, and a greater increase in high-density lipoprotein cholesterol, compared to the control group (P<0.05). However, there were no significant statistical differences between the two groups in fasting blood glucose, low-density lipoprotein cholesterol or homocysteine.（6）There were no significant statistical differences between the two groups in ovarian volume or antral follicle count (P>0.05).（7）The study group had a higher ovulation rate compared to the control group (P<0.05).（8）Both groups showed no abnormal liver or kidney function indicators, and the incidence of adverse reactions was not statistically different. Conclusions The combination of Dingkundan with drospirenone-ethinylestradiol tablets（Ⅱ）can improve menstrual cycles in patients with PCOS of kidney-deficiency and liver-stagnation type, reduce traditional Chinese medicine syndrome scores, lower total testosterone and androstenedione, improve glucose and lipid metabolism and uric acid metabolism, and increase ovulation rates. No increase in the incidence of adverse drug reactions has been observed.